Covid19OPTIC-19NCT04838106
Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales
An observational study of Covid19 and Myocardial Infarction, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This retrospective cohort study aims to characterise outcomes for patients treated on an intensive care unit (ICU) with COVID-19 in England and Wales, one year after discharge from hospital. Outcomes will be compared with patients admitted as an emergency to an ICU for other conditions. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Covid19, Myocardial Infarction, Stroke
- What is being tested?
- Not applicable as observational study
- How many people
- 319,600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2020to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency between 1st July 2016 and 1st July 2020 who survived to hospital discharge.
Who may be able to join
- Age 16 years or over
- Admitted to an adult, general ICU in England or Wales as an emergency (unplanned)
- Admitted to ICU for either: a) confirmed COVID-19 between 1st January to 1st July 2020 or b) without confirmed COVID-19 between 1st July 2016 and 1st July 2020-
Who cannot join
- Patients who died in hospital after treatment on an ICU
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales: a Comparative Retrospective Cohort Study (OPTIC-19)
This retrospective cohort study aims to characterise outcomes for patients treated on an intensive care unit (ICU) with COVID-19 in England and Wales, one year after discharge from hospital. Outcomes will be compared with patients admitted as an emergency to an ICU for other conditions. The study will use existing national audit data linked to routine healthcare datasets.
Read the detailed description
Across England and Wales, over 10,000 patients have been treated for severe coronavirus disease 2019 (COVID-19) on an intensive care unit. Around 60% survived to leave hospital. It is unknown how survivors' severe COVID-19 infection, or the treatment they received on the intensive care unit, will affect their long-term health. Understanding what happens to these patients can help ensure they receive suitable care from their General Practitioner (GP) and other National Health Service (NHS) services after they leave hospital.
This study will follow up survivors for 1 year after discharge from hospital. The investigators will use data collected by the Intensive Care National Audit and Research Centre (ICNARC) to identify patients who were treated on an ICU for COVID-19. The investigators will then use NHS data to see whether these patients were readmitted to hospital and why. Information from the Office of National Statistics will identify whether patients died. By linking different sources of patient data, the investigators will estimate the health risks faced by survivors of severe COVID-19. These risks will be compared to those in patients treated on an ICU for other conditions.
- Conditions
- Covid19, Myocardial Infarction, Stroke, Critical Illness, Heart Failure, Deep Vein Thrombosis
- Being tested
- Not applicable as observational study
- Medical subject headings
- COVID-19, Myocardial Infarction, Stroke, Critical Illness, Heart Failure, Venous Thrombosis, Pulmonary Embolism, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable as observational studyOther
Not applicable as observational study.
| Study group | Role | What they receive |
|---|---|---|
| Covid19 | Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency with confirmed COVID-19 between 1st January to 1st July 2020. Receives: Other: Not applicable as observational study | |
| Non Covid19 | Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency without confirmed COVID-19 between 1st July 2016 and 1st July 2020. Receives: Other: Not applicable as observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
Mortality after discharge from hospital
Measured: One year
Secondary outcomes (5)
Rate of emergency hospital admission
Emergency hospital admission
Measured: one year
Rate of emergency hospital admission for respiratory infection
Emergency hospital admission for respiratory infection
Measured: one year
Rate of emergency hospital admission for a major adverse cardiac event
Emergency hospital admission for a major adverse cardiac event (myocardial infarction, stroke, heart failure)
Measured: one year
Rate of emergency hospital admission for a venous thrombotic event
Emergency hospital admission for a venous thrombotic event (deep vein thrombosis or pulmonary embolism)
Measured: one year
Rate of development of end stage renal failure
Development of end stage renal failure treated by renal replacement therapy
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Aug 2020
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 319,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Intensive Care National Audit & Research Centre
- Responsible party
- Sponsor
- Investigators
- Peter Watkinson, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838106
- Sponsor's protocol ID
- PID15456
- Other IDs
- 21/SC/0021, 21/CAG/0017
- Acronym
- OPTIC-19
- Status last verified
- Jul 2024
- First submitted
- 7 Apr 2021
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to privacy and legal implications.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales: a Comparative Retrospective Cohort Study (OPTIC-19)
- ClinicalTrials.gov ID
- NCT04838106
- Acronym / sponsor ID
- OPTIC-19 / PID15456
- Conditions
- Covid19, Myocardial Infarction, Stroke, Critical Illness, Heart Failure, Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 319,600 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Intensive Care National Audit & Research Centre
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective cohort study aims to characterise outcomes for patients treated on an intensive care unit (ICU) with COVID-19 in England and Wales, one year after discharge from hospital. Outcomes will be compared with patients admitted as an emergency to an ICU for other conditions. The study will use existing national audit data linked to routine healthcare datasets.
Detailed description
Across England and Wales, over 10,000 patients have been treated for severe coronavirus disease 2019 (COVID-19) on an intensive care unit. Around 60% survived to leave hospital. It is unknown how survivors' severe COVID-19 infection, or the treatment they received on the intensive care unit, will affect their long-term health. Understanding what happens to these patients can help ensure they receive suitable care from their General Practitioner (GP) and other National Health Service (NHS) services after they leave hospital.
This study will follow up survivors for 1 year after discharge from hospital. The investigators will use data collected by the Intensive Care National Audit and Research Centre (ICNARC) to identify patients who were treated on an ICU for COVID-19. The investigators will then use NHS data to see whether these patients were readmitted to hospital and why. Information from the Office of National Statistics will identify whether patients died. By linking different sources of patient data, the investigators will estimate the health risks faced by survivors of severe COVID-19. These risks will be compared to those in patients treated on an ICU for other conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid19 | – | Other: Not applicable as observational studyPatients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency with confirmed COVID-19 between 1st January to 1st July 2020. |
| Non Covid19 | – | Other: Not applicable as observational studyPatients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency without confirmed COVID-19 between 1st July 2016 and 1st July 2020. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency between 1st July 2016 and 1st July 2020 who survived to hospital discharge.
Key inclusion criteria (3 listed)
- Age 16 years or over
- Admitted to an adult, general ICU in England or Wales as an emergency (unplanned)
- Admitted to ICU for either: a) confirmed COVID-19 between 1st January to 1st July 2020 or b) without confirmed COVID-19 between 1st July 2016 and 1st July 2020-
Key exclusion criteria (1 listed)
- Patients who died in hospital after treatment on an ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable as observational studyNot applicable as observational study. | Other | Covid19, Non Covid19 |
Primary outcome
Mortality Rate
Time frame: One year
Mortality after discharge from hospital
5 secondary outcomes
Rate of emergency hospital admission
Time frame: one year
Rate of emergency hospital admission for respiratory infection
Time frame: one year
Rate of emergency hospital admission for a major adverse cardiac event
Time frame: one year
Rate of emergency hospital admission for a venous thrombotic event
Time frame: one year
Rate of development of end stage renal failure
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to privacy and legal implications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Watkinson, MD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Myocardial Infarction, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Rate (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.